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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382R
In Commercial Distribution

  • 30014613340089 ()
20382R

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382
In Commercial Distribution

  • 30014613339304 ()
20382

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWSI-02
In Commercial Distribution

  • 16974900600091 ()
  • 26974900600104 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640123 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. Black color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640116 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640024 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640017 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Alinity m System
ABBOTT MOLECULAR INC.
08N53-002
In Commercial Distribution

  • 00884999048034 ()
08N53-002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
m2000rt Instrument System
ABBOTT MOLECULAR INC.
9K15-01
In Commercial Distribution

  • 00884999031814 ()
9K15-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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